Back to results

Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

Primary Purpose

Pain, Postoperative, Brachial Plexus Block

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine HCl

Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Interscalene nerve block, total shoulder arthroplasty, pain management, OBAS, QoR-15

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
Patients 18 years of age and older
Able to provide informed consent for him or herself

Exclusion Criteria

Chronic pain syndromes
Chronic opioid use (>1 month) with OME >5 mg/day OR acute opioid use (< 1 month) with OME > 30 mg/day.
Body mass index (BMI) > 45 kg/m2
Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. *defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever
Personal or family history of malignant hyperthermia.
Major systemic medical problems such as:
- Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
- Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
- Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation < 93% on room air.
- History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury.
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal).
o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia.
Known to be currently pregnant or actively breastfeeding++
o ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf)
Impaired cognition (e.g. Alzheimer's disease, moderate to severe dementia, encephalopathy)
Non-English speaking

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

liposomal bupivacaine single-shot interscalene blockade

continuous interscalene nerve blockade

Arm Description

Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine

Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.

Outcomes

Primary Outcome Measures

Change in pain intensity scores

Self-reported pain intensity scores measure using pain scores of 0 (no pain) to 10 (worst pain imaginable)

Opioid consumption

Reported in mg oral morphine equivalents (OME)

Secondary Outcome Measures

Quality of recovery score (QoR)

15 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).

Overall benefit of analgesic score (OBAS)

Patient survey assessing patient experience with postoperative pain regimen. 7 question scoring system entails a combination of pain intensity, adverse opioid events, and patient satisfaction. The total OBAS score is calculated via 'sum items Q1 through Q6 and add [4 - score from Q7].' This score consists of a 29-point scale ranging from 0 (best) to 28 (worst); therefore, lower OBAS scores indicate more analgesic benefit.

Full Information

NCT ID

NCT05005260

First Posted

August 8, 2021

Last Updated

March 23, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05005260

Brief Title

Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

Official Title

Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 14, 2021 (Actual)

Primary Completion Date

March 18, 2023 (Actual)

Study Completion Date

March 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Brachial Plexus Block

Keywords

Interscalene nerve block, total shoulder arthroplasty, pain management, OBAS, QoR-15

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Unblinded

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

liposomal bupivacaine single-shot interscalene blockade

Arm Type

Active Comparator

Arm Description

Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine

Arm Title

continuous interscalene nerve blockade

Arm Type

Active Comparator

Arm Description

Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.

Intervention Type

Drug

Intervention Name(s)

Bupivacaine HCl

Intervention Description

Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.

Intervention Type

Drug

Intervention Name(s)

Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj

Intervention Description

Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).

Primary Outcome Measure Information:

Title

Change in pain intensity scores

Description

Self-reported pain intensity scores measure using pain scores of 0 (no pain) to 10 (worst pain imaginable)

Time Frame

Post-Operative Day 1

Title

Opioid consumption

Description

Reported in mg oral morphine equivalents (OME)

Time Frame

Post-Operative Day 1

Secondary Outcome Measure Information:

Title

Quality of recovery score (QoR)

Description

Time Frame

up to post-operative day 7

Title

Overall benefit of analgesic score (OBAS)

Description

Time Frame

up to post-operative day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty). Patients 18 years of age and older Able to provide informed consent for him or herself Exclusion Criteria Chronic pain syndromes Chronic opioid use (>1 month) with OME >5 mg/day OR acute opioid use (< 1 month) with OME > 30 mg/day. Body mass index (BMI) > 45 kg/m2 Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. *defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever Personal or family history of malignant hyperthermia. Major systemic medical problems such as: Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history. Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation < 93% on room air. History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury. Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal). o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia. Known to be currently pregnant or actively breastfeeding++ o ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf) Impaired cognition (e.g. Alzheimer's disease, moderate to severe dementia, encephalopathy) Non-English speaking

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason K Panchamia, DO

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

We'll reach out to this number within 24 hrs